Device Dossier
Guiding Screw SMS - Needle guide
Device Dossier for Guiding Screw SMS - Needle guide (Non-implantable needle guide, single-use, Class III, sponsor Surgical Instruments). ARTG record,…
- GMDN category: Non-implantable needle guide, single-use
Intended purpose
The guiding screws are accessories designed to guide and then fix Microdeep depth electrodes in place during implantation and use. The trajectory is to be determined beforehand using stereotactic coordinates. The guiding screw is attached transcutaneously to the bone using special stereotactic equipment. The service life of the guiding screw is usually one week (limited to short-term usage, i.e. < 30 days).
Functional description
Guiding Screws are titanium 2.5mm diameter cylinders with screw threads at either end, available in various lengths. The screws are inserted into a drill hole that is made in the bone using stereotactic instruments. Once inserted, the Guiding Screws act as guide for insertion of a stylet and then a Microdeep depth electrode. Finally, the Microdeep depth electrode is secured onto the Guiding Screw by means of a cap on the electrode, to maintain the correct position of the Microdeep electrode.